GUEST COLUMNISTS

• Rating Risk Events: Why We Should Replace The Risk Priority Number (RPN) With The Adjusted Risk Likelihood (ARL)

  The most common approach for rating risk events in the medical device and pharmaceutical industries is identified by FMEA. While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

• An Introduction To Trending In Environmental Monitoring Programs

  Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

• FDA Inspections: Are Changes On The Horizon?

  A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.

• Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across

  Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.

• Life Sciences Dealmaking Aims At Early Stages Amid COVID-19

  Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets.This article highlights takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals in 2020.

• Complying With Batch Release: Auditing Electronic Batch Records

  This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation. 

• Addressing The Challenges Of MSCs Will Reveal A Bright Future For This Regenerative Medicine Modality

  Safety and efficacy data have started to provide a solid basis for building confidence in new and promising treatment modalities such as mesenchymal stem cells (MSCs). 

• Implementing EU MDR and IVDR: Lessons Learned, Part 1

  The transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is not an easy undertaking. This first article in a two-part series highlights the sections that need close attention regarding economic operator responsibilities, overall QMS considerations, and common challenges during implementation. Ensure a smooth transition and avoid pitfalls!